MEXILETINE HYDROCHLORIDE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Mexiletine Hydrochloride.
| Product ID | 50742-241_3b641000-11ad-43fb-be6f-2be03b5b1cd8 |
| NDC | 50742-241 |
| Product Type | Human Prescription Drug |
| Proprietary Name | MEXILETINE HYDROCHLORIDE |
| Generic Name | Mexiletine Hydrochloride |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-01-26 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA214352 |
| Labeler Name | Ingenus Pharmaceuticals, LLC |
| Substance Name | MEXILETINE HYDROCHLORIDE |
| Active Ingredient Strength | 250 mg/1 |
| Pharm Classes | Antiarrhythmic [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-01-26 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0093-8739 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 0093-8740 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 0093-8741 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 0527-4107 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 0527-4108 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 0527-4109 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 10135-730 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 10135-731 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 10135-732 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 31722-036 | Mexiletine hydrochloride | Mexiletine hydrochloride |
| 31722-037 | Mexiletine hydrochloride | Mexiletine hydrochloride |
| 31722-038 | Mexiletine hydrochloride | Mexiletine hydrochloride |
| 42291-624 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 42291-625 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 42291-626 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 50742-239 | MEXILETINE HYDROCHLORIDE | Mexiletine hydrochloride |
| 50742-240 | MEXILETINE HYDROCHLORIDE | Mexiletine hydrochloride |
| 50742-241 | MEXILETINE HYDROCHLORIDE | Mexiletine hydrochloride |
| 51407-379 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 51407-380 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 51407-381 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 62559-820 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 62559-821 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 62559-822 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 62756-955 | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride |
| 62756-956 | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride |
| 62756-957 | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride |
| 63629-1962 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 63629-1963 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 63629-1964 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 63629-2145 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 63629-9179 | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride |
| 68151-2347 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 68151-2986 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |
| 68151-2985 | Mexiletine Hydrochloride | Mexiletine Hydrochloride |